MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE; HUMIDIFIER NEBULIZER KIT

Model Number	NEB KIT W ADAPTER STERILE WATER 1000 ML
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample device is not available for analysis.Additionally, no photo was available.No investigation can be performed and the defect could not be confirmed.Therefore, root cause of failure could not be determined.
Event or Problem Description
The customer reported that during use on patient their nebulizer kit's mists works fine initially but when they turn off the flow and restarted it again it does not work anymore.No patient harm was reported.

• Brand Name: AIRLIFE
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9578747
• Report Number: 8030673-2020-00067
• Device Sequence Number: 14223015
• Product Code: CCK
• UDI-Device Identifier: 10885403199141
• UDI-Public: (01)10885403199141(11)20190820(10)0004110253
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NEB KIT W ADAPTER STERILE WATER 1000 ML
• Device Catalogue Number: CK0010
• Device Lot Number: 4110253
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other